PURPOSE: The purpose of this study was to compare the effectiveness of the Flutter device (Axcan Scandipharm Inc, Birmingham, AL) with that of the PEP Mask (Astra Tech AB, Molndal, Sweden) in the treatment of adults with cystic fibrosis (CF). METHODS: Forty-two adults (mean age 29.0 +/- 8.4 years) were recruited from the Adult Cystic Fibrosis Program at St Michael's Hospital and were randomly assigned to airway clearance treatment with either the Flutter device or the PEP Mask. Pulmonary function tests, the Quality of Well-Being Scale (QWB), and the Chronic Respiratory Disease Questionnaire (CRQ) were administered 1 month postrecruitment and every 3 months thereafter for 13 months. RESULTS: Using linear regression, the mean slope or annual rate of change of forced expiratory volume in 1 second (FEV1) percent predicted was -2.0 (+/- 8.1) for the Flutter group and -4.2 (+/- 8.0) for the PEP group (p = 0.4). There were no significant between-group differences in the slopes of the QWB (p = 0.3) or CRQ (p = 1.0) total scores. The power to detect differences was low (0.137). CONCLUSIONS: When comparing the Flutter device and the PEP Mask in the treatment of adults with CF over a 13-month period, there were no significant differences in pulmonary function or health-related quality of life. A much larger sample would be needed to conclude with confidence that there were no between-group differences. Therefore, additional research is needed to further examine the effectiveness of the Flutter device and the PEP Mask.

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